Mindray

FDA UDI

Class I (US FDA UDI)

by Nanjing Mindray Bio-Medical Electronics Co., Ltd

Identity

Trade Name: Mindray FDA UDI
Generic Name: Operating table torso positioner FDA UDI
Model / Reference: A66XXU Back plate for shoulder operation FDA UDI

Identifiers

Primary DI / UDI-DI: 06948350528895 FDA UDI
FDA Product Code: FQO FDA UDI
GMDN Term: Operating table torso positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4960 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Operating table torso positioner

Mindray by Nanjing Mindray Bio-Medical Electronics Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table torso positioner.

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SINGLE LOOP PREPPER REPLACEMENT PAD — AliMed, LLC · Class I
Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
Universal Lateral Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
SINGLE LOOP PREPPER — AliMed, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Nanjing Mindray Bio-Medical Electronics Co., Ltd

Sources (1)

FDA UDI aa70cc08-537d-4fba-8dd6-7c4c67de0799 32 fields · synced Jun 6, 2026